Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19 : a pragmatic randomised clinical trial (COVID HELMET)
(2020) In Trials 21(1).- Abstract
Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to... (More)
Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021. Discussion: We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. Trial registration: ClinicalTrials.gov NCT04395807. Registered on 20 May 2020.
(Less)
- author
- Tverring, Jonas LU ; Åkesson, Anna LU and Nielsen, Niklas LU
- organization
- publishing date
- 2020
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- COVID-19, Helmet CPAP, HFNC, Randomised controlled trial protocol, Ventilator-free days
- in
- Trials
- volume
- 21
- issue
- 1
- article number
- 994
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:33272319
- scopus:85097026244
- ISSN
- 1745-6215
- DOI
- 10.1186/s13063-020-04863-5
- language
- English
- LU publication?
- yes
- id
- 70ac0c52-3324-4133-b526-a3dc7322410c
- date added to LUP
- 2020-12-09 13:46:53
- date last changed
- 2024-08-22 08:52:56
@article{70ac0c52-3324-4133-b526-a3dc7322410c, abstract = {{<p>Background: Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking. Methods: We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021. Discussion: We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. Trial registration: ClinicalTrials.gov NCT04395807. Registered on 20 May 2020.</p>}}, author = {{Tverring, Jonas and Åkesson, Anna and Nielsen, Niklas}}, issn = {{1745-6215}}, keywords = {{COVID-19; Helmet CPAP; HFNC; Randomised controlled trial protocol; Ventilator-free days}}, language = {{eng}}, number = {{1}}, publisher = {{BioMed Central (BMC)}}, series = {{Trials}}, title = {{Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19 : a pragmatic randomised clinical trial (COVID HELMET)}}, url = {{http://dx.doi.org/10.1186/s13063-020-04863-5}}, doi = {{10.1186/s13063-020-04863-5}}, volume = {{21}}, year = {{2020}}, }